Dr.MetabolicMD said:Worth answering the question that was asked rather than the one behind it.
Coming at Dr.MetabolicMD’s question from a different direction. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.
The figures, for anyone assembling their own picture. If you are going to change something, change one thing and give it long enough to express itself. Four weeks is the usual minimum for anything pharmacological on this board, and two weeks of data has told you almost nothing.
A narrower follow-up, since the general answer is now clear:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
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Browse GL Biochemdan_philly said:If you are going to change something, change one thing and give it long enough to express itself.
This is where I part company with the consensus forming above. Not convinced. The evidence being cited is consistent with the conclusion and also consistent with two other conclusions nobody has ruled out.
OP back with an update, since a thread like this is useless without one.
The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.